A Phase 1, First-In-Human Study of the Investigational COVID-19 Vaccine SC-Ad6-1 in Healthy Volunteers
Phase 1
Recruiting
- Conditions
- Covid19
- Interventions
- Biological: SC-Ad6-1
- Registration Number
- NCT04839042
- Lead Sponsor
- Moat Biotechnology Corporation
- Brief Summary
This is a single-centre, open-label, first-in-human, single ascending dose and multiple dose study to assess the safety, reactogenicity, and immunogenicity of the SC-Ad6-1 investigational product when administered via the intramuscular (IM), intranasal (IN) or inhaled (IH) route in healthy volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 230
Inclusion Criteria
- Adult males and females, 18 to 60 years of age (inclusive)
- Body mass index ≥ 18.0 and ≤ 32.0 kg/m2, with a body weight ≥ 50 kg at screening
- Must have been fully vaccinated against COVID-19 and received last dose not less than 3 months prior to Day 1 (High Dose #3 I.M. and I.N. booster arms only), not less than 5 months prior to Day 1 (High Dose #4 I.N. booster arm only) and not less than 12 months prior to Day 1 (I.H. booster arms and I.N or I.H. multiple dose booster arms only)
Key
Exclusion Criteria
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease
- History of chronic respiratory disorders including asthma, emphysema, interstitial lung disease, pulmonary hypertension, recurrent pneumonia, or recent (≤14 days prior to Screening) or ongoing respiratory tract infection
- History of thrombosis (e.g., deep vein thrombosis, pulmonary embolism, etc.), any coagulation dysregulation disorder, or a history of thrombosis noted in immediate family members
- History of any neurological disorders or seizures including Guillain-Barre syndrome, with the exception of febrile seizures during childhood
- Known previous infection with SARS-CoV-2 or presence of antibodies against SARS-CoV-2 or a positive SARS-CoV-2 PCR test (non-booster arms only)
- Any history of malignant disease ≤5 years prior to registration
- History of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description SC-Ad6-1 Low Dose Intranasal SC-Ad6-1 Low Dose SC-Ad6-1, I.N., single-dose (Day 1) SC-Ad6-1 High Dose #4 Intranasal Booster SC-Ad6-1 High Dose #4 SC-Ad6-1, I.N., single-dose booster (Day 1) SC-Ad6-1 High Dose #1 Intranasal SC-Ad6-1 High Dose #1 SC-Ad6-1, I.N., single-dose (Day 1) SC-Ad6-1 High Dose #2 Intranasal SC-Ad6-1 High Dose #2 SC-Ad6-1, I.N., single-dose (Day 1) SC-Ad6-1 Low Dose Intramuscular SC-Ad6-1 Low Dose SC-Ad6-1, I.M., single-dose (Day 1) SC-Ad6-1 High Dose #1 Intramuscular SC-Ad6-1 High Dose #1 SC-Ad6-1, I.M., single-dose (Day 1) SC-Ad6-1 Low Dose Inhaled SC-Ad6-1 Low Dose SC-Ad6-1, I.H., single-dose booster (Day 1) SC-Ad6-1 Medium Dose Intramuscular SC-Ad6-1 Medium Dose SC-Ad6-1, I.M., single-dose (Day 1) SC-Ad6-1 Medium Dose Intranasal SC-Ad6-1 Medium Dose SC-Ad6-1, I.N., single-dose (Day 1) SC-Ad6-1 Multiple Dose Intranasal SC-Ad6-1 Multiple Dose SC-Ad6-1, I.N., multiple-dose (Day 1 and Day 22) SC-Ad6-1 High Dose #3 Intranasal Booster SC-Ad6-1 High Dose #3 SC-Ad6-1, I.N., single-dose booster (Day 1) SC-Ad6-1 Multiple High Dose #2 Intranasal or Inhaled SC-Ad6-1 Multiple High Dose #2 SC-Ad6-1, I.N. or I.H., multiple-dose (Day 1 and Day 29) SC-Ad6-1 High Dose #2 Intramuscular SC-Ad6-1 High Dose #2 SC-Ad6-1, I.M., single-dose (Day 1) SC-Ad6-1 Multiple Dose Intramuscular SC-Ad6-1 Multiple Dose SC-Ad6-1, I.M., multiple-dose (Day 1 and Day 22) SC-Ad6-1 Multiple High Dose Intranasal SC-Ad6-1 Multiple High Dose SC-Ad6-1, I.N., multiple-dose (Day 1 and Day 29) SC-Ad6-1 High Dose #3 Intramuscular Booster SC-Ad6-1 High Dose #3 SC-Ad6-1, I.M., single-dose booster (Day 1) SC-Ad6-1 Medium Dose Inhaled SC-Ad6-1 Medium Dose SC-Ad6-1, I.H., single-dose booster (Day 1) SC-Ad6-1 Multiple High Dose Inhaled SC-Ad6-1 Multiple High Dose SC-Ad6-1, I.H., multiple-dose (Day 1 and Day 29)
- Primary Outcome Measures
Name Time Method Number of participants with solicited local and systemic adverse events for 7 days Following Each Dose 7 days following each dose Solicited local adverse events are defined as pain, redness and swelling at the site of dose administration for the intramuscular arms, are defined as stuffy nose, runny nose, nasal discomfort, loss of smell, sore or scratchy throat for the intranasal arms and are defined as stuffy nose, runny nose, dry mouth, mouth sores, sore or scratchy throat and cough for the inhalation arms. Solicited systemic adverse events for all routes of administration are defined as fever, headache, muscle pain, joint pain, fatigue, nausea or vomiting, and chills.
Incidence and severity of adverse events (AEs), including withdrawals due to safety or tolerability reasons Up to 106 days following first dose Humoral response to SARS-CoV-2 as measured by neutralizing antibodies using wild-type virus assay Up to 106 days following first dose
- Secondary Outcome Measures
Name Time Method Humoral response to SARS-CoV-2 as measured by mucosal IgA antibodies to the SARS-CoV-2 spike protein (ELISA) and total mucosal IgA Up to 106 days following first dose Measurement of cytokine-producing T cells specific for the SARS-CoV-2 spike protein (ELISpot) Up to 106 days following first dose Measurement of adenovirus 6 (Ad6) neutralizing antibodies (anti-drug antibodies (ADA)) Up to 106 days following first dose Humoral response to SARS-CoV-2 as measured by serum IgG and IgA antibodies to the SARS-CoV-2 spike protein (ELISA) Up to 106 days following first dose
Trial Locations
- Locations (1)
Tetherex Study Site
🇦🇺Brisbane, Queensland, Australia